Abstract: Objective To retrospectively analyze real-world data on adverse drug reactions (ADR) associated with camrelizumab, characterize the profile, and identify contributors in order to provide evidence for rational drug use. Methods Reports about adverse reactions from hospitalized cancer patients treated with camrelizumab for injection between May 2021 and March 2025 in Guangxi Zhuang Autonomous Region were retrieved from the China Hospital Pharmacovigilance System. The demographics of patients, medications, and severity of ADR were statistically analyzed. Results Among the 481 camrelizumab-treated patients, Serious ADR accounted for over half of the reported cases. ADR were much more prevalent in males than in females. The proportion of middle-aged and elderly patients was relatively large. Primary malignancies were predominantly esophageal cancer, hepatocellular carcinoma and lung cancer. ADR primarily involved the hematopoietic/lymphatic systems, with such major manifestations as myelosuppression syndrome, reactive cutaneous capillary endothelial proliferation, and hepatotoxicity. Univariate analysis disclosed significant differences in age and treatments. Multivariate logistic regression confirmed age and combination therapy as independent risk factors for serious ADR. One-way ANOVA pointed to significantly higher proportions of serious ADR in patients with esophageal cancer, hepatocellular carcinoma, and nasopharyngeal carcinoma. Conclusion Clinical use of camrelizumab requires heightened vigilance regarding the patients’ age, treatment regimens (particularly combination chemotherapy), and specific tumor types (esophageal, hepatic, nasopharyngeal). Drugs should be monitored when necessary to ensure the safety of medication.

Key words: Camrelizumab, Esophageal Cancer, Hepatocellular Carcinoma, Lung Cancer, Adverse Drug Reactions, Myelosuppression Syndrome, Reactive Cutaneous Capillary Endothelial Proliferation, Hepatotoxicity